Effectiveness of a multicomponent intervention to reduce social isolation and loneliness in community-dwelling elders: A randomized clinical trial. Study protocol.

Abstract

This study aims to evaluate the effectiveness of a multicomponent intervention in non-institutionalized older people. This effectiveness will be assessed in terms of reducing social isolation and loneliness and improving Health-Related Quality of Life. The concern for social isolation and loneliness in non-institutionalized older adults has increased in recent decades. In addition, their relationship with numerous negative health outcomes is amply demonstrated. A mixed-method design including a cluster randomized controlled clinical trial and an exploratory qualitative study with focus groups was used. Each study group consists of 57 subjects. The experimental group will be subjected to a multicomponent intervention comprising six domiciliary face-to-face sessions and five telephone calls that will be interspersed. Interventions will be conducted by healthcare professionals and volunteers. The control group will not be subjected to any systematized intervention. We are going to consider social isolation, loneliness, and Quality of Life as the primary outcomes. However, the factors that influence both primary outcomes and the feasibility of the intervention in clinical practice will also be assessed. Despite the negative influence of social isolation and loneliness on clinical outcomes is widely evidenced, few early detection programs are available, especially interventions at the community setting. This study will examine the effectiveness of the intervention in the Spanish community setting. At the same time, this study will identify the feasibility of this intervention in Primary Care clinical practice. Substantial evidence indicates the detrimental health impact of social isolation and loneliness, particularly on mental wellness. Knowing that mental disorders are associated with high economic cost, this project would have strong clinical implication to inform nursing practice on managing social isolation and loneliness. The findings may also inform primary health policy setting in Spain and the wider European countries.